MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5

Catalog Number 320-10-05

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision due to instability.The reverse humeral tray disassociated from the stem.

Manufacturer Narrative

The revision reported was likely the result of either cross-threading or incomplete seating of the reverse torque defining screw allowing it to back out over time, which led to the humeral adapter tray disassociating from the humeral stem and joint instability.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8261932
• MDR Text Key: 133567011
• Report Number: 1038671-2019-01032
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-10-05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention